Current through all regulations passed and filed through September 16, 2024
(A)
Dangerous drugs shall be dispensed by a pharmacist for
inpatients pursuant to an original patient-specific order issued by a
prescriber or a protocol or pre-printed order as authorized in accordance with
rule 4729:5-3-12 of the
Administrative Code. All controlled substance prescriptions or medication
orders shall be issued in accordance with 21 CFR part 1306 (7/1/2019) and 21
CFR part 1311 (7/1/2019).
(1)
Medication orders for inpatients of an institutional
facility transmitted to a pharmacy by use of an electronic drug record keeping
system may be considered an original order for the dispensing of drugs. Access
to such system for entering and transmitting original orders shall be
restricted to personnel authorized in accordance with written policies and
procedures of the institutional facility. If the authorized personnel entering
the order into the system is not the prescriber, there shall be a system in
place requiring the positive identification of the prescriber for each order
within a reasonable period of time which shall be made readily
retrievable.
(2)
Oral orders issued by a prescriber for inpatients of an
institutional facility may be transmitted to a pharmacist by personnel
authorized in accordance with written policies and procedures of the
institutional facility. Such orders shall be transcribed by the pharmacist,
noting the full name(s) of the authorized personnel transmitting the order.
Oral orders issued by a prescriber and transmitted by authorized personnel
shall be verified by the prescriber using positive identification within a
reasonable time and as required by the written policies and procedures of the
facility.
Authorized personnel at an
institutional facility may transcribe an oral order of a prescriber, including
those received telephonically, in accordance with rule
3701-16-09 or
3701-17-13 of the Administrative
Code and transmit the written transcription to the pharmacy by facsimile
machine or electronic prescription transmission system in accordance with
written policies and procedures of the institutional facility. The transcribed
order shall include the positive identification of the authorized facility
personnel who transcribed and transmitted the order to the
pharmacy.
(a)
Oral orders for non-controlled substances issued by a
prescriber for inpatients of an institutional facility may be transmitted to a
pharmacy intern by personnel authorized by, and in accordance with, written
policies and procedures of the facility if the pharmacist on duty who is
personally supervising the activity of the intern determines that the intern is
competent to perform this function.
(i)
The intern shall immediately transcribe the order,
document the full name of the prescriber and, if transmitted by the
prescriber's agent, the full name of the agent and shall review the order with
the pharmacist on duty. Prior to dispensing, positive identification of the
intern and the pharmacist on duty shall be recorded to identify the
responsibility for the receipt of the oral order.
(ii)
The pharmacist
on duty is responsible for the accuracy of the prescription.
(iii)
The pharmacist
on duty must be immediately available to answer questions or discuss the
prescription with the prescriber or the prescriber's agent.
(b)
Oral
orders for non-controlled substances issued by a prescriber for inpatients of
an institutional facility may be transmitted to a certified pharmacy technician
in pursuant to rule
4729:3-3-04 of the
Administrative Code by personnel authorized by, and in accordance with, written
policies and procedures of the facility. Oral orders issued by a prescriber and
transmitted by authorized personnel shall be verified by the prescriber using
positive identification within a reasonable time and as required by the written
policies and procedures of the facility.
(3)
Medication orders
for inpatients of an institutional facility transmitted to a pharmacy by use of
a facsimile machine shall be transmitted by personnel authorized by, and in
accordance with, written policies and procedures of the facility.
Telephonic orders transcribed by
authorized residential care facility personnel and transmitted to a pharmacy by
use of a facsimile machine shall comply with the requirements of rule
3701-16-09 or
3701-17-13 of the Administrative
Code and the policies and procedures of the institutional
facility.
A facsimile shall only be valid as an
order if a pharmacy retains a printed copy of a facsimile prescription or an
electronic copy of the facsimile prescription in accordance with paragraph (B)
of this rule.
(B)
All
non-controlled hard copy medication orders, including facsimiles, may be
electronically maintained, provided that the system creates and maintains
electronic records in accordance with the following:
(1)
All hard copy
medication orders for non-controlled dangerous drugs may be electronically
filed and then destroyed after one hundred and eighty days from the date of
creation or receipt. Disposal of the hard copy shall use a secure method of
destruction to ensure privacy and confidentiality of the
contents.
(2)
All hard copy medication orders electronically filed in
accordance with this rule shall be scanned front and back in full color (i.e.
retains color information and/or color graphics in the document) via technology
designed to capture information in one form and reproduce it in an electronic
medium presentable and usable to an end user. Prior to scanning, the written or
faxed order shall be clearly notated to indicate it has been received by the
pharmacy in a manner that does not destroy any of the original information
contained on the prescription but prevents the unauthorized duplication of the
prescription.
(3)
A record or image once created shall be unalterable but
may be annotated as necessary so long as the original record or image is still
available for review and the individual that made the annotation is
noted.
(4)
The electronic form shows the exact and legible image
of the original hard copy medication order.
(5)
All hard copy
orders filed electronically in accordance with this rule shall be deemed the
original prescription.
(C)
All orders for
drugs for inpatients shall include the following:
(2)
Name, strength, and dosage form of
drug;
(3)
Directions for use, including route of
administration;
(5)
The ordering
prescriber's positive identification, which may be maintained in the patient's
medical record at the institutional facility; and
(6)
If applicable,
the positive identification of the authorized individual transmitting the order
on behalf of the prescriber.
(D)
An institutional
pharmacy shall develop and maintain written stop order policies or other
methods of assuring that drug orders are not continued inappropriately in
accordance with the status of the patient.
(E)
Drugs may be
dispensed for outpatients by an institutional pharmacy pursuant to an original
prescription of a prescriber in accordance with rule
4729:5-5-15 of the
Administrative Code. All outpatient prescriptions dispensed by an institutional
pharmacy shall comply with the following outpatient pharmacy
requirements:
(1)
Labeling requirements in accordance with rule
4729:5-5-06 of the
Administrative Code;
(2)
Record keeping requirements in accordance with rule
4729:5-5-04 of the
Administrative Code;
(3)
Patient counseling requirements pursuant to rule
4729:5-5-09 of the
Administrative Code;
(4)
Prescription filing requirements pursuant to rule
4729:5-5-03 of the
Administrative Code;
(5)
Manner of processing requirements pursuant to rule
4729:5-5-10 of the
Administrative Code;
(6)
Serial numbering requirements pursuant to rule
4729:5-5-13 of the
Administrative Code;
(7)
Pick-up station requirements pursuant to rule
4729:5-5-14 of the
Administrative Code;
(8)
Patient profile requirements pursuant to rule
4729:5-5-07 of the
Administrative Code;
(9)
Reporting of all drugs pursuant to division 4729:8 of
the Administrative Code; and
(10)
Prospective drug
utilization review requirements pursuant to rule
4729:5-5-08 of the
Administrative Code.
(F)
Outpatient
prescriptions may be transferred by an inpatient pharmacy to an outpatient
pharmacy in accordance with rule
4729:5-5-11 of the
Administrative Code.
(G)
A pharmacist may modify an outpatient prescription
pursuant to rule
4729:5-5-16 of the
Administrative Code.
(H)
An original signed prescription for a schedule II
controlled substance prepared in accordance with federal and state requirements
and issued for a resident in a long-term care facility may be transmitted by
the prescriber or the prescriber's agent to the dispensing pharmacy by
facsimile. The facsimile shall serve as the original written prescription and
shall be received and maintained pursuant to rules
4729:5-5-10 and
4729:5-5-15 of the
Administrative Code. The original signed prescription must remain with the
patient's records at either the prescriber's office or the long-term care
facility.
(I)
A prescription or medication order, to be valid, must
be issued for a legitimate medical purpose by an individual prescriber acting
in the usual course of the prescriber's professional practice. The
responsibility for the proper prescribing is upon the prescriber, but a
corresponding responsibility rests with the pharmacist who dispenses the
prescription. An order purporting to be a prescription issued not in the usual
course of bona fide treatment of a patient is not a prescription and the person
knowingly dispensing such a purported prescription, as well as the person
issuing it, shall be subject to the penalties of law.
(J)
A pharmacy
providing emergency kits for use by a nursing home or residential care facility
pursuant to rule
4729:5-9-03.1 of the
Administrative Code must receive a valid outpatient prescription issued in
accordance with rule
4729:5-5-15 of the
Administrative Code prior to the administration of the initial dose of a
controlled substance drug contained in the kit. The pharmacy providing the
emergency kit shall be responsible for generating and maintaining a record of
the dispensing of the initial dose of a controlled substance drug obtained from
the kit in compliance with the record keeping requirements set forth in rule
4729:5-9-02.3 of the
Administrative Code.